During the development and production of many pharmaceutical and chemical products it is necessary to perform various tests and evaluations and maintain various records, then to manipulate the results of these tests and evaluations, and prepare various reports that interpret and summarize those results. Such activities are generally performed in accordance with a set of laws and guidelines provided by the agency, such as the FDA, which controls or approves the market-release of the products and Standard Operating Procedures (SOP's), prepared by the manufacturer's internal Quality Assurance department (QA), or by an independently contracted auditor.
It is estimated that in the pharmaceutical laboratory 70% or more laboratory staff time is spent on documentation related to these tests, not actual laboratory operations. Cycle times from sample arrival to certificate of analysis are often quoted at 10 to 15 days. The QC/QA review cycle often challenges the data or the analysis, generating investigations to support the conclusions. Out of spec or out of trend results discovered during review are well beyond the time of the operation that generated them. To reduce cycle time in the laboratory, it is imperative to present error free, valid measurements.
Several computer-based data management systems specifically intended for use in such analytical laboratories have been designed over the years and are known generically as Laboratory Information Management Systems (LIMS). LIMS systems and chromatography data systems are common systems in pharmaceutical labs. While these systems often archive the analytical results, and provide reports, they are usually oriented too late in the process to insure original data integrity.
The inventors believe that a critical need exists to capture, validate and secure laboratory data as close to the source as possible. Technology needs to be developed which will perform this function with simple equipment and clear interfaces for laboratory personnel and instruments.
Under present procedures, authorized analysts are provided with SOP's and, using properly calibrated instrumentation, perform the aforementioned tests and manually record the aforementioned data in accordance therewith. Once all data has been collected, it is transcribed into a batch record within a computer for interpretation and manipulation, and thereafter, for compilation into such reports as might be dictated by the SOP. The agency, auditor, or QA inspector can view the report(s), while simultaneously viewing the SOP and the supporting data to interpret the report and judge both its validity and its acceptability.
The approval and certification agencies for pharmaceutical products and many chemical products, such as the FDA, generally require the performance of such tests and evaluations and the production of such reports in conjunction with both development and production. Performance of these tests, access to the resulting data, and ability to manipulate it must be strictly limited to only authorized individuals. These requirements result in a tremendous physical and logistical problem, as the evaluation periods can be lengthy and huge quantities of data often accrue. Since present methods fail to recognize many anomalies in these requirements until the report-writing phase, that being the final phase in the process, tremendous delays and expense result when such anomalies prove results erroneous or invalid, polluting the batch record and causing the need for extensive re-testing so late in the process.
LIMS systems of some sort have always been essential tools in such research and development labs, in-process testing labs, and quality assurance labs as are involved in such testing and reporting. Typically, a LIMS is a software program loaded into the computer that receives the data collected from the instruments, either electronically or manually, manipulates and interprets it, maintains it, and presents it for independent inclusion in the required report(s). This information can thus be sorted and organized within the batch record or externally into various report formats based upon the type of report required.
As recently as the nineteen-seventies, laboratory notebooks and handwritten notes were the preferred tools used to track and record information. Thereafter, although handwritten notebooks are still in use today for certain data, custom-designed LIMS were configured by individual laboratories to allow certain analytical instruments to communicate directly with the main server. Such “in-house” systems, which are still being used to this day by many labs, can take considerable time and cost to develop, can require considerable resources and attention to maintain, yet still require many manual steps and documentation stages in order to satisfy most approval and certification requirements.
Even with the use of a LIMS, once data has been collected, it must first be downloaded, either manually or electronically, into the LIMS' batch record file. Each such recordation thus created presents an additional need for preservation and additional point of possible transcription error. Additionally, the recording of such data, which is generally proprietary, in and from numerous locations, increases the potential for access to this data by unauthorized individuals and presents a serious security concern.
Generally, data is either recorded manually or stored within a data collection system associated with the collecting instrumentation itself. For example, if an electronic scale is used, the weight data collected will normally be stored in a memory within that scale. Although this data can be transferred electronically to the server to minimize error, the need to maintain and report details about that original record is not eliminated.
Since the introduction of customized LIMS, great strides have been made in the electronic interfacing of instrumentation and data manipulating equipment. These have made feasible and provided an incentive for the development of a truly universal system to connect all instrumentation with both the server and the SOP's to thereby integrate all data, procedures, and results into one cohesive batch record which can produce one cohesive and inclusive report. This further provides an opportunity to reduce the record-keeping burden by minimizing record maintenance requirements, to improve security, and to expedite the evaluation process. Further, the cumbersome need to manually compare and interpret test results against the SOP can be eliminated and the discovery of invalidities and discrepancies prior to the final stage of the process can be realized.
By linking the testing, the recordation and manipulation of resulting data, and the generation of reports directly with the process itself, as provided by the present invention, it becomes possible to greatly streamline and expedite the approval process.